Assessing a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert

NCT03482531 | Unknown

• 1 other identifier: PHRC 2018-03
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Induction of labor is a common obstetric procedure that is routinely performed worldwide. However, when cervical conditions are not favorable (bishop \<6), induction of labor is preceded by cervical ripening, usually with prostaglandins. The method of ripening most commonly used in France (89% of maternity wards) is the dinoprostone vaginal insert. In the majority of hospitals in France, dinoprostone vaginal inserts are usually placed in the morning, because of the higher availability of personnel (midwives and nurses). However, morning placement might increase the likelihood of the delivery occurring at night, since the mean interval between the insert placement and delivery is about 13 to 20 hours. Many studies have now shown that the risk of obstetrical complications, as well as neonatal morbidity and mortality is increased when deliveries occur at night. Several factors have been suggested behind the increased morbidity at night, including the lower number of personnel working, the fatigue associated with night work and the disruption of the circadian rhythm, and the insufficient supervision of residents. Very few studies have evaluated the importance of the timing of placement of the intravaginal dinoprostone insert, and its influence on the occurrence of night deliveries. Some investigators have recently performed a retrospective study at Angers university hospital that assessed the time interval between placing the dinoprostone vaginal insert and delivery, as well as the factors impacting the time to delivery, and found that nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion increased the time to delivery. Moreover, the investigators proposed a regression equation that allows to calculate the mean time from insert placement to delivery for each patient, and have decided to incorporate it in the routine practice. The investigators have decided to analyze the validity of the mathematical model. The consequence would be, thanks to a personalized timing for placement of dinoprostone vaginal insert based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes), a decreased number of deliveries occurring between 12 p.m. and 6 a.m.

Conditions

Dinoprostone Vaginal Insert

Keywords

limit nocturnal activity; cervical ripening

Outcome Measures

Primary Outcomes (1)

• Difference (in minutes) between the actual time to delivery compared to the predicted time

  there will be different categories: * less than 180 minutes * more than 180 but less than 360 minutes * more than 360 but less than 540 minutes * more than 540 but less than 720 minutes * more than 720 minutes

  2 days

Secondary Outcomes (7)

• rate of deliveries

  2 years

• the Apgar score

  1, 3 and 5 minutes after delivery

• neonatal potential of hydrogen (pH)

  1 hour

• neonatal intensive care hospitalization

  12 hours

• post-partum bleeding

  24 hours

Study Arms (2)

before group

In the "before" group, the investigators retrospectively included 405 patients who had a dinoprostone vaginal insert for cervical ripening before induction of labor, between January 2015 and September 2016. Multivariate and regression analysis showed that the factors significantly increasing the time to delivery were: Nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion. The investigators also described a regression equation that allows to calculate the mean time from insert placement to delivery for each patient.

after group

The investigators will prospectively include all eligible patients with a vaginal dinoprostone insert for cervical ripening during the next two years, starting on April 1st, 2018. At Angers hospital, there are around 600 cases of dinoprostone vaginal inserts per year, so the investigators will be able to include 400 to 500 patients during the study's duration. The equation will be incorporated when scheduling patients for cervical ripening with vaginal dinoprostone insert. The main objective of this study is to analyze to evaluate our mathematical model. One of the secondary objectives is to analyze whether the use of the personalized scheduling based on the mathematical model would decrease the rate of nocturnal deliveries (between midnight and 6 a.m.).

Other: mathematical model

Interventions

mathematical model OTHER

mathematical model: regression equation that calculates the mean time from insert placement to delivery for each patient, based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes)

after group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients with a vaginal dinoprostone insert for cervical ripening ( because of not favorable cervical conditions (bishop \<6) and needing induction of labor)

You may qualify if:

• have cervical ripening with the dinoprostone vaginal insert
• weeks gestational age (GA) and beyond
• singleton pregnancies
• cephalic presentations

You may not qualify if:

• term \< 34 weeks GA
• previous history of cesarean section
• women who refuse to participate in the study or have their data used.
• twin pregnancy
• prostaglandin allergies

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University hospital

Angers, Maine Et Loire, 49000, France

RECRUITING

MeSH Terms

Interventions

Models, Theoretical

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

BOUET Pierre-emmanuel, doctor

CONTACT

(+33)02.41.35.42.13; PierreEmmanuel.Bouet@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 29, 2018
• Study Start: April 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

FR (1)